Non-invasive glucose measurements – database and calibration building (RSP-07)

Aim of the study

Calibration and glucose prediction performance assessment for the WM3.4 prototype, with focus on applicability in clinical and home settings.

Study description

Fortyeight participants completed thirty outpatient study days, each consisting of four measurement sessions performed on both the thenar and wrist sites. An additional twentyfour participants completed two inclinic study days to provide controlled reference conditions. Noninvasive optical measurements from the WM3.4 prototype were paired with capillary glucose reference values to evaluate bodysite performance, collectiondepth requirements, and the feasibility of an outpatient study design for calibration model development.

Conclusions

The study identified the best measurement location (the thenar area of the hand) and demonstrated that reliable calibration and glucose prediction models could be derived from both clinical and real-life measurement settings.

Study registration

For more information, see the study registration on ClinicalTrials.gov (NCT03368209).

Related peer-reviewed publication

Lundsgaard-Nielsen SM, Pors A, Banke SO, Henriksen JE, Hepp DK, Weber A. Critical-depth Raman spectroscopy enables home-use non-invasive glucose monitoring. PLoS One. 2018 May 11;13(5):e0197134. doi: https://doi.org/10.1371/journal.pone.0197134

About the study

Study period: December 2015 to May 2017

Prototype ID: WM3.4 (higher efficiency spectrometer)  

Comparator: HemoCue 201RT (BGM); Dexcom G4 (CGM)

Site: Department of Endocrinology, Odense University Hospital, Denmark

No of participants: 72

Profile of participants: Adults with all types of diabetes